The following data is part of a premarket notification filed by Biopsys Medical, Inc. with the FDA for Modified Biopsy Needle.
| Device ID | K945133 |
| 510k Number | K945133 |
| Device Name: | MODIFIED BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | BIOPSYS MEDICAL, INC. 27130 A PASEO ESPADA, SUITE 1424 San Juan Capistrano, CA 92675 |
| Contact | Mark A Cole |
| Correspondent | Mark A Cole BIOPSYS MEDICAL, INC. 27130 A PASEO ESPADA, SUITE 1424 San Juan Capistrano, CA 92675 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-20 |
| Decision Date | 1994-11-09 |